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Below is the entire pre-conference and conference programme with the possibility to download the presentations of those speakers who authorized it. The presentations are in PDF-format only. Please note that the copyright on these presentations remain with their authors and that anybody who would want to use some of the content, should explicitly refer to its author and the context of the conference.

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Wednesday 20 May: Pre-Conference workshops

WORKSHOP 1: Implementation of the EU Clinical Trial Regulation – Opportunities and Threats to Early Medicines Development

Session 1: Single Portal: opportunity or burden for early medicines development?
Concept, compromises and implementation plan for the Single Portal
Fergus Sweeney, EMA, United Kingdom
Hopes and fears for the single portal from a Pharma company conducting Phase I trials in Europe
Maria-Gabriela Di Matteo, Belgium
How will the Single Portal work for a Phase I CRO?
Elizabeth Allen, United Kingdom
Needs for IT support in our National Competent Authority due to the Clinical Trial Regulation and the Single Portal
Karina Markersen, Danish Health and Medicines Authority, Denmark
Session 2: Single Dossier: Will national early stage trials suffer or benefit?
Sponsor / CRO view
Bruno Speder, Belgium
Regulatory Authority view
Maria Antonia Serrano Castro, AEMPS, Spain
Ethics Committee view
Saskia de Weerd, NVMETC, The Netherlands
Session 3: National implementation of the Clinical Trial Regulation – how can we ensure improved conditions for early phase studies?
Implementation in France
Cécile Delval, ANSM, France
Implementation in Belgium
Greet Musch and Kristof Bonnarens, FAMHP, Belgium
Implementation in United Kingdom
Martyn Ward, MHRA, United Kingdom
Implementation in Germany
Thomas Sudhop, BfArM, Germany

WORKSHOP 2: An Introduction to PK/PD Modelling

General strategic approaches towards PK/PD modelling in clinical development [author has not authorized on-line publication]
F. Hourcade-Potelleret, Switzerland

Scientific background of PK/PD modelling
Bernd Meibohm, USA

 

Examples of PK/PD Modelling: Interactive Session I

PK/PD approach in a first-in human clinical trial for a BACE inhibitor in Alzheimer’s disease [author has not authorized on-line publication]
Vassilios Aslanis, Florence Hourcade-Potelleret, Switzerland
Assessment of concentration-QT relationships in pooled Phase I trials using a real example
Philippe Grosjean, Jérôme Msihid and Silvain Nicolas, France

Examples of PK/PD Modelling: Interactive Session II

PopPK and PBPK modeling in paediatric development programs [author has not authorized on-line publication]
Akash Khandelwal, Germany
PK/PD modeling and simulation for efficacy and safety of corticosteroids in asthma and inflammation
Hartmut Derendorf, USA
Population PK/PD modelling of methylphenidate accounting for placebo response and tachyphylaxis [author has not authorized on-line publication]
Roberto Gomeni, France

Thursday 21 May 2015

Session 1: What does the future of phase I research look like in Europe?
New transparency rules in early phase non-therapeutic trials.  Open forum discussion introduced by Ulrike LorchUnited Kingdom
The new EU regulation: an asset for early drug development in Europe?  Open forum discussion introduced by Clara Heering, Belgium
[pending authorization by the speaker]
Session 2: Global challenges in early development of medicines
Overcoming challenges in early drug development: optimizing CNS Drug discovery using neuroimaging [author has not authorized on-line publication]
Richard HargreavesUSA
Overcoming challenges in early drug development: focus on biologicals [author has not authorized on-line publication]
Martin Wright, Switzerland
RNA interference (RNAi) as a therapeutic modality: From worms, to flies and now humans [pending authorization by the speaker]
Akshay Vaishnaw, USA

Drug-drug interactions between biologicals and small molecules
Bernd MeibohmUSA

 

Parallel workshops repeated on Friday 22 May
1. Neuroimaging versus CSF sampling as a scientific tool in human pharmacology:
Mark Schmidt (PPT 1, PPT 2, PPT 3), Belgium and Ilan Rabiner (PPT 4), United Kingdom
2. GCP and GMP inspections in phase I: what can be learned?
Barbara Schug (PPT 1), Germany and Jean-Luc Golnez (PPT 2) & Dominique Delforge (PPT 3) , Belgium
3. How statistical tools can help your proof of concept studies.
Nicolas Bonnet, France
4. Outlook on the upcoming medical device and in vitro diagnostics regulations in the EU
Eric Klasen, Switzerland and Ingrid KlingmannBelgium
Session 3: European setting for early drug development in special populations
Pediatric drug development - do we need a PIP so early in development? American versus European approach
Angelica Joos, Belgium
Specifics of early orphan drug development in Europe [author has not authorized on-line publication]
Khazal Paradis, The Netherlands
Revisiting the pharmacokinetics in patients with impaired renal function in the light of the latest FDA and EMA guidelines
Eric Legangneux, France and Kasra Shakeri-Nejad, Germany